The present invention relates generally to surgical tools and methods of implantation. More particularly, it relates to surgical tools and methods used in conjunction with heart repair procedures, including tools for holding prostheses such as annuloplasty rings or bands.
Improvements in cardiopulmonary bypass and myocardial protection and standardization of surgical techniques have lead to increasing interest in valve reconstruction procedures. See, for example, Ormiston J A, Shah P M, Tei C, et al., Size and Motion in the Mitral Valve Annulus in Man, Circulation 1981;64:113; Dagum P, Green GR, Glasson J R, et al., Potential Mechanism of Left Ventricular Outflow Tract Obstruction After Mitral Ring Annuloplasty, J Thorac Cardiovasc Surg. 1999;117:472-80; David T E, Armstrong S, Sun Z, Left Ventricular Function After Mitral Valve Surgery, J Heart Dis 1995; 4:S175-80; and Duran C, Perspectives for Acquired Valvular Disease, Advanced Cardiac Surgery, Vol. 4, 1993.
As highlighted by the above, annuloplasty bands and rings have been recognized as being highly useful in a variety of surgical procedures, including mitral and tricuspid valve repair. In general terms, current techniques for implanting an annuloplasty ring or band includes the annuloplasty device initially being secured to a holder that facilitates simplified manipulation of the annuloplasty device during the implantation procedure. Because heart valve annulus size varies from patient to patient, a plurality of sizers are typically used to identify the appropriate size for the holder. Once the appropriate size is identified, the correspondingly-sized holder is selected from an inventory of different sized holders. This process can be time consuming and requires large inventories of both sizers and holders.
Once the appropriately-sized holder/annuloplasty device has been selected, sutures are then placed around all or portions of the valve annulus at spaced intervals. To this end, a typical suture arrangement entails looping a suture through the annular tissue that opposing ends or segments of the suture define a suture pair. With this technique, a plurality of sutures are employed, thus defining a plurality of suture pairs (i.e., once looped through the annular tissue, opposing ends or segments of the suture extend from the annular tissue to define a “suture pair”). Spacing along the annular tissue between the segments associated with a particular suture pair can vary depending upon whether it is desired to plicate (or reduce) a region of the annulus to which the suture pair is applied (e.g., a suture pair will be spaced approximately 4 mm in width where no plication is necessary, and approximately 5-6 mm in width where plication is desired). Regardless, the sutures are then brought through the annuloplasty device (with an equal spacing between suture pair segments relative to the annuloplasty device determined by whether or not plication is desired).
The process of passing the sutures through the annuloplasty device occurs while the prosthesis is maintained by the holder/tool at a point spaced from the valve annulus. For virtually all procedures in which multiple sutures, and thus multiple suture segment pairs, are required, once threaded through the annuloplasty device, the suture segments must be discretely positioned and held away from the surgical site so as to not interfere with threading of other suture segments through the annuloplasty device, to avoid entanglement with other suture segments, maintain an organizational flow to the threading of sutures, etc. The conventional approach to this suture management requirement entails securing the sutures within one or more separate suture holding devices located away from the surgical field. Unfortunately, the sutures can become entangled and it is sometimes difficult to identify corresponding segments of a suture pair.
Once all necessary suture segments have been placed through the annuloplasty device, the annuloplasty device is then removed from the holder. Conventional annuloplasty holders entail the use of one or more sutures that secure the annuloplasty device to the holder. With this approach, to release the annuloplasty device, a sharp instrument such as a knife or scalpel is used to cut the suture(s) that otherwise connects the annuloplasty device to the holder frame. While accepted, this has the disadvantage of requiring the use of a sharp instrument in close proximity to sensitive anatomical structures and in even closer proximity to the prosthetic repair device which typically has a fabric cover that can otherwise be relatively easily severed. Further, known annuloplasty device holder designs give rise to the potential of improperly separating the device-retaining suture(s) in more than one location. This may increase the chance that a stray piece of the cut suture(s) may remain in the patient's body.
Various systems for use in heart repair procedures are disclosed in U.S. Pat. Nos. 5,011,481; 5,290,300; 5,496,336; 5,638,402; 5,522,884; 6,174,332; 6,283,993; 6,558,416; and 6,719,786. Prosthesis and surgical methods for implanting prostheses for addressing heart disorders are described in Okada Y, Shomura T, Yamura Yl, et al., Comparison of the Carpentier and Duran Prosthetic Rings Used in Mitral Reconstruction, Ann Thorac Surg 1995; 59:658-63; Duran C M G; Ubago J L M; Clinical and Hemodynamic Performance of a Totally Flexible Prosthetic Ring for Atrio-Ventricular Valve Reconstruction, Ann Thorac Surg 1976; 22:458-63; and Van Rijk-zwikker GL, Mast F, Shepperheyn J J, et al., Comparison to Flexible Rings for Annuloplasty of the Mitral Valve, Circulation, 1990; 82 (Suppl. IV):IV 58-64.
Annuloplasty devices continue to be highly important tools for repairing heart valves. Unfortunately, the instruments used in connection with implantation of the annuloplasty prosthesis are cumbersome. Therefore, a need exists for an implantation tool and related surgical method for implanting an annuloplasty device.